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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00083889




Registration number
NCT00083889
Ethics application status
Date submitted
3/06/2004
Date registered
4/06/2004
Date last updated
26/01/2010

Titles & IDs
Public title
SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Scientific title
A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
Secondary ID [1] 0 0
A6181034
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Interferon-alfa
Treatment: Drugs - SU011248

Active comparator: 2 -

Experimental: 1 -


Treatment: Drugs: Interferon-alfa
3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity

Treatment: Drugs: SU011248
50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS), Core Radiology Assessment
Timepoint [1] 0 0
Day 28 of each 6-week cycle: duration of treatment phase
Primary outcome [2] 0 0
Progression-Free Survival (PFS), Investigator's Assessment
Timepoint [2] 0 0
Day 28 of each 6-week cycle: duration of treatment phase
Secondary outcome [1] 0 0
Objective Response, Core Radiology Assessment
Timepoint [1] 0 0
Day 28 of each 6-week cycle: duration of treatment phase
Secondary outcome [2] 0 0
Objective Response, Investigator's Assessment
Timepoint [2] 0 0
Day 28 of each 6-week cycle: duration of treatment phase
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Clinic visit or telephone contact every 2 months until death
Secondary outcome [4] 0 0
Time to Tumor Progression (TTP), Core Radiology Assessment
Timepoint [4] 0 0
Randomization to first documentation of tumor progression: duration of treatment phase
Secondary outcome [5] 0 0
Time to Tumor Progression (TTP), Investigator's Assessment
Timepoint [5] 0 0
Randomization to first documentation of tumor progression: duration of treatment phase
Secondary outcome [6] 0 0
Duration of Response (DR), Core Radiology Assessement
Timepoint [6] 0 0
Day 28 of each cycle: duraton of treatment phase
Secondary outcome [7] 0 0
Duration of Response (DR), Investigator's Assessment
Timepoint [7] 0 0
Day 28 of each cycle: duration of treatment phase
Secondary outcome [8] 0 0
FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale
Timepoint [8] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [9] 0 0
FACT-Kidney Symptom Index (FKSI) Subscale
Timepoint [9] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [10] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G)
Timepoint [10] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [11] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale
Timepoint [11] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [12] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale
Timepoint [12] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [13] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale
Timepoint [13] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [14] 0 0
Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale
Timepoint [14] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [15] 0 0
EuroQoL Five Dimension (EQ-5D) Health State Index
Timepoint [15] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [16] 0 0
Euro-QoL Visual Analog Scale (EQ-VAS)
Timepoint [16] 0 0
Day 1 & 28 of each cycle: duration of treatment phase
Secondary outcome [17] 0 0
Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis
Timepoint [17] 0 0
Day 1 & Day 28, Cycle 1 to Cycle 4
Secondary outcome [18] 0 0
Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis
Timepoint [18] 0 0
Day 1 & Day 28, Cycle 1 to Cycle 4
Secondary outcome [19] 0 0
Incremental Cost Effectiveness Ratio (ICER)
Timepoint [19] 0 0
post study measurement
Secondary outcome [20] 0 0
Ctrough Concentrations of SU011248
Timepoint [20] 0 0
Day 28 of Cycle 1 to Cycle 4
Secondary outcome [21] 0 0
Ctrough Concentrations of Metabolite SU012662
Timepoint [21] 0 0
Day 28 of Cycle 1 to Cycle 4
Secondary outcome [22] 0 0
Ctrough Concentrations of SU011248 and Active Metabolite SU012662
Timepoint [22] 0 0
Day 28 of Cycle 1 to Cycle 4

Eligibility
Key inclusion criteria
* Histologically confirmed renal cell carcinoma of clear cell histology with metastases
* Evidence of measurable disease by radiographic technique
* Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
* History of or known brain metastases
* Serious acute or chronic illness or recent history of significant cardiac abnormality

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
Accrual to date
Final
750
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Lismore
Recruitment hospital [2] 0 0
Pfizer Investigational Site - St. Leonards
Recruitment hospital [3] 0 0
Pfizer Investigational Site - South Brisbane
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Woodville South
Recruitment hospital [5] 0 0
Pfizer Investigational Site - East Melbourne
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Perth
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Victoria
Recruitment postcode(s) [1] 0 0
2480 - Lismore
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment postcode(s) [7] 0 0
36184 - Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New Hampshire
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
Wisconsin
Country [28] 0 0
Brazil
State/province [28] 0 0
RJ
Country [29] 0 0
Brazil
State/province [29] 0 0
RS
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
France
State/province [34] 0 0
Cedex 15
Country [35] 0 0
France
State/province [35] 0 0
Lyon
Country [36] 0 0
France
State/province [36] 0 0
Paris Cedex 13
Country [37] 0 0
France
State/province [37] 0 0
Rennes
Country [38] 0 0
France
State/province [38] 0 0
Saint Herblain
Country [39] 0 0
France
State/province [39] 0 0
Vandoeuvre Les Nancy
Country [40] 0 0
Germany
State/province [40] 0 0
Aachen
Country [41] 0 0
Germany
State/province [41] 0 0
Essen
Country [42] 0 0
Germany
State/province [42] 0 0
Hannover
Country [43] 0 0
Germany
State/province [43] 0 0
Ulm
Country [44] 0 0
Italy
State/province [44] 0 0
Modena
Country [45] 0 0
Italy
State/province [45] 0 0
Napoli
Country [46] 0 0
Italy
State/province [46] 0 0
Pavia
Country [47] 0 0
Italy
State/province [47] 0 0
Roma
Country [48] 0 0
Poland
State/province [48] 0 0
Warszawa
Country [49] 0 0
Poland
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Gdansk
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Poland
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Krakow
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Poland
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Lodz
Country [52] 0 0
Poland
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Lublin
Country [53] 0 0
Poland
State/province [53] 0 0
Poznan
Country [54] 0 0
Poland
State/province [54] 0 0
Wroclaw
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Kaluga Region
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Chelyabinsk
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Moscow
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Saint-Petersburg
Country [59] 0 0
Russian Federation
State/province [59] 0 0
St. Petersburg
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Tomsk
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
Country [62] 0 0
Spain
State/province [62] 0 0
Navarra
Country [63] 0 0
Spain
State/province [63] 0 0
Madrid
Country [64] 0 0
Spain
State/province [64] 0 0
Sevilla
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Cardiff
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Lancashire
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Middlesex
Country [68] 0 0
United Kingdom
State/province [68] 0 0
London
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Sutton Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00083889